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NDC 68437-0012-84 Sulfur Facial Wash 3 g/100mL Details

Sulfur Facial Wash 3 g/100mL

Sulfur Facial Wash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GRISI Hnos, S.A DE C.V. The primary component is SULFUR.

Product Information

NDC	68437-0012
Product ID	68437-012_eb0475c6-c75a-55a1-e053-2a95a90a69e9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sulfur Facial Wash
Proprietary Name Suffix	Acne Cleanser
Non-Proprietary Name	Sulfur
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	g/100mL
Substance Name	SULFUR
Labeler Name	GRISI Hnos, S.A DE C.V
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M006
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68437-0012-84 (68437001284)

Pricing Information	N/A
NDC Package Code	68437-012-84
Billing NDC	68437001284
Package	250 mL in 1 BOTTLE, PLASTIC (68437-012-84)
Marketing Start Date	2019-07-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8d6dfaf2-92ac-9a34-e053-2a95a90a9ca4 Details

Active Ingredients/Ingredientes activos

Sulfur/Azufre3%

Purpose/Utilidad

Acne treatment/Tratamiento para el acné

Uses/Usos

■ For the treatment of acne, helps clear up acne pimples/Para el tratamiento del acne, ayuda e eliminar espinillas del acne

Warnings/Precauciones

■ For external use only/Solo par uso externo

■ Not for children under 12 years/No par ninos menores de 12 anos

Do not use/No user en

■ Broken skin/Heridas abiertas ■ Large areas of the skin/Grandes superficies de piel

When using this product/Cuando use este producto

■ Avoid contact with the eyes. If product gets in the eyes rinse with water/Evire el contacto con los ojos. Si el producto entra en contacto con los ojos, enjuague con agua.

■ Apply only to the areas with acne/Aplique únicamente en áreas con acné

St op use and ask a doctor if/Suspenda su uso y consulte al medico si

■ if skin irritation occurs or gets worse, stop use and consult a physician/Aparece alguna irritacion en la piel o esta empeora, suspenda su uso y consulte a su medico.

Keep out of the reach of children

Mantengase fuera del alcance de los ninos

Directions/Modo de uso

■ Clean the skin thoroughly before applying this product/Limpiar bien la piel antes de aplicar el producto. ■ Wet affected area with warm water/Humedecer la zona afectada con aqua tibia.

■ Cover the entire affected area with a thin layer and massage until obtaining abundant lather. Leave for 1 minute and rinse thoroughly; one to three times a day/Cubrir el area afectada con una capa delgada y masajear hasta obtener espuma. Deja actuar por 1 minuto y enjuagar cuidadosamente; repetir de una a tres veces al dia ■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor/Debido a que puede ocurrir un exceso de resequedad en la piel, comience con una aplicación al día e incremente de los a tres veces al dia cuando sea necesario o segun las indicaciones del médico

■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day/Si aparece alguna resequedad o descamación, reduzca la aplicación a una vez al día o cada dos días

Inactive Ingredients/Ingredientes inactivos

Acrylates Copolymer, Aminomethyl Propanol, Caprylyl Glycol, Cocamide MEA, Cocamidopropyl Betaine, Coco-Betaine, Decylene Glycol, Fragrance, Glycerin, Glycol Distearate, Laureth-10, Lauroyl/Myristoyl Methyl Glucamide, Limonene, Linalool, PEG-150, Phenoxyethanol, Polyquaternium-7, Polysorbate 80, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA, Water

Questions or comments/Dudas o comentarios

1-833-794-3320

Package Label

INGREDIENTS AND APPEARANCE

SULFUR FACIAL WASH ACNE CLEANSER

sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68437-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII: U1G23TFV1K)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO-BETAINE (UNII: 03DH2IZ3FY)
DECYLENE GLYCOL (UNII: S57M60MI88)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
LAURETH-10 (UNII: BD7AST04GA)
LAUROYL/MYRISTOYL METHYL GLUCAMIDE (UNII: SC667B999P)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68437-012-84	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	07/08/2019

Labeler - GRISI Hnos, S.A DE C.V (810320754)

Name	Address	ID/FEI	Business Operations
Establishment
GRISI Hnos, S.A DE C.V		810320754	manufacture(68437-012)

Revised: 10/2022

Document Id: eb0475c6-c75a-55a1-e053-2a95a90a69e9

Set id: 8d6dfaf2-92ac-9a34-e053-2a95a90a9ca4

Version: 2

Effective Time: 20221014